Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

Port delivery system with ranibizumab

5 evidence topics · 3 sources

Surgically implanted refillable ranibizumab reservoir

“The FDA approved ranibizumab 100 mg/ml for use with an ocular implant that continuously releases the medication over 6 months.” (opens the source at this quote in a new tab)
“The implant is surgically inserted into the eye in the operating room and can be refilled every 6 months with an office procedure.” (opens the source at this quote in a new tab)
“Approximately 98% of patients could receive continuous treatment for 6 months before requiring a refill or supplemental ranibizumab.” (opens the source at this quote in a new tab)
“In 2022, the implant was voluntarily recalled due to concerns about septum dislodgment.” (opens the source at this quote in a new tab)
“The implant was re-introduced to the market in 2024.” (opens the source at this quote in a new tab)

Endophthalmitis across Ladder, Archway, and Portal

“The United States Prescribing Information has a Boxed Warning for endophthalmitis” (opens the source at this quote in a new tab)
“Twelve endophthalmitis events were reported in 11 patients (11/555 [2.0%]) through March 12, 2021.” (opens the source at this quote in a new tab)
“Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications.” (opens the source at this quote in a new tab)

Archway: ocular adverse events of special interest with denominators through week 40

“Ocular adverse events of special interest were reported in 47 patients (19.0%) and 10 patients (6.0%) in the PDS Q24W and monthly ranibizumab arms, respectively.” (opens the source at this quote in a new tab)
“endophthalmitis occurred in 4 patients (1.6%) in the PDS Q24W arm; all events were serious and occurred outside of the postoperative period at days 57, 59, 161, and 282.” (opens the source at this quote in a new tab)
“Iritis occurred in 50 patients (20.2%) in the PDS Q24W arm, with 48 patients experiencing events in the postoperative period, consistent with expected postoperative inflammation.” (opens the source at this quote in a new tab)
“In the PDS Q24W arm, 18 patients (7.3%) required 22 additional surgical procedures related to ocular adverse events of special interest, including cataract extraction, conjunctival repair, and vitrectomy.” (opens the source at this quote in a new tab)

Archway: supplemental ranibizumab before the first refill-exchange

“A total of 246 PDS-treated patients were assessed for supplemental ranibizumab treatment at week 16, week 24, or both, excluding 2 patients who discontinued study treatment before week 16.” (opens the source at this quote in a new tab)
“In total, 4 PDS-treated patients (1.6%) who were assessed for supplemental treatment received supplemental treatment before the first refill-exchange procedure.” (opens the source at this quote in a new tab)

Port delivery system endophthalmitis: basis of the boxed warning, severity, and timing of onset

“This warning was issued due to the observation that PDS-treated patients experienced endophthalmitis at a 3-fold higher rate (1.7%) compared with patients receiving monthly intravitreal injections (0.5%) during the controlled phase of the PDS nAMD studies of Ladder and Archway.” (opens the source at this quote in a new tab)
“all patients experienced moderate (4/11 [36.4%]) or severe (7/11 [63.6%]) endophthalmitis when events were analyzed by greatest intensity.” (opens the source at this quote in a new tab)
“There were 2 cases (2/555 [0.4%]) of postoperative endophthalmitis consistent with acute postoperative endophthalmitis. All other cases had a late onset and occurred >37 days after the PDS implant insertion procedure and were consistent with delayed onset endophthalmitis.” (opens the source at this quote in a new tab)